BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 2041540 · Received March 10, 2011

    Report

    Report Number
    1717344-2011-00184
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Report Date
    February 17, 2011
    Manufacturer
    COVIDIEN LP (VALLEYLAB)
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN REQUESTED BUT TO DATE THE INCIDENT SAMPLE HAS NOT BEEN REC'D FOR EVAL. IF THE SAMPLE IS REC'D OR IF ADD'L INFO PERTINENT TO THE INCIDENT IS OBTAINED A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSTRUMENT STOPPED SEALING. THERE WAS NO PT INJURY, NO TISSUE DAMAGE AND NO BLOOD LOSS. NO MEDICAL INTERVENTION WAS REQUIRED. THE SITE WAS UNABLE TO PROVIDE ADD'L INFO ON THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP (VALLEYLAB) 189921

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK